Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Enforcement Comeback? FDA Predicts 1,767% Increase In US Inspections In FY ’22, Matching Pre-Pandemic Levels

Executive Summary

An FDA budget request released on 28 May estimates that domestic GMP inspections of US device makers will increase from a mere 75 in the current 2021 fiscal year to 1,400 in FY 2022. It also asks for an increase of $18.8m to pay for inspections of all commodities the agency oversees.

You may also be interested in...



At Best, FDA Will Carry Out Only Half Of Domestic Surveillance Inspections In FY 2021, Report Says

A 5 May report from the US FDA says that even under the most favorable COVID-19 conditions the agency’s inspections of makers of medical and tobacco products will likely be cut in half this fiscal year. The FDA also announced it will launch an agency-wide Inspectional Affairs Council to “plan and coordinate inspectional activities.”

From Electronic Docs To FOIA Requests, FDA Lays Bare Its Process For Remote Regulatory Assessments

A document from the US FDA obtained by Medtech Insight advises medical device manufacturers on how a voluntary Remote Regulatory Assessment will unfold. RRAs are being conducted by the agency in lieu of on-site facility inspections because of the COVID-19 pandemic.

COVID-19: US FDA’s Hahn Slams The Brakes On Domestic Inspections ‘For The Health And Well-Being Of Our Staff’

A little more than a month after it put the kibosh on conducting facility inspections in China, the agency announced late on 18 March that it was suspending routine surveillance audits in the US, too.

Topics

UsernamePublicRestriction

Register

MT143997

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel